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Medical Letter on the CDC & FDA

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HIV/AIDS Treatment



FDA approves Sculptra (injectable poly-L-lactic acid)



September 5th, 2004

Dermik Laboratories, the U.S. dermatology arm of Aventis (AVE), announced the U.S. Food and Drug Administration (FDA) has approved Sculptra (injectable poly-L-lactic acid) as the only product for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV.

Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. Commercial availability of Sculptra is expected in the third quarter of this year.

"We are very pleased that the FDA has recognized the need for Sculptra with its expedited review and approval," said John Leone, president of Aventis...


Source: Medical Letter on the CDC & FDA (2004-09-05)

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